Congruence Medical Solutions LLC
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Manufacturing & Lab Equipment
Company Overview
About
Congruence Medical Solutions LLC is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:United States
Founded:2015
Employees:1,850
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval TVPKG8
PMDA · #APR-6BD8TG21 · 2022-02-01
Drug Approval PDR8GY
FDA · #APR-38EH9QRN · 2018-11-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-5K5LEDPP
Issued: 2020-11-24
Expires: 2025-12-07
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-P0TP7FKA
Issued: 2020-08-10
Expires: 2025-03-22
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-PNBXDK6U
Issued: 2020-01-12
Expires: 2025-07-28
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-QR49Z9ZN
Issued: 2020-09-19
Expires: 2025-07-11
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Key facts about Congruence Medical Solutions LLC
- Congruence Medical Solutions LLC is headquartered in the United States.
- Congruence Medical Solutions LLC was founded in 2015.
- Congruence Medical Solutions LLC has 1,850 employees.
- Congruence Medical Solutions LLC's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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